Primatene Mist OTC: Why We Believe Caution is Needed

Originally posted: Dec 2018 — UPDATED: June 2021

Disclaimer: As board-certified allergists we do not recommend Primatene Mist as a treatment for asthma symptoms. If you or someone you are responsible for is considering Primatene Mist, we recommend discussing asthma treatment with us (or your personal allergy and asthma specialist) before using this or other OTC treatments. 

If you’re a fan of this once-popular product, you can thank the manufacturers who came up with a reformulation that would satisfy environmental concerns. By switching up the propellant used in the inhaler, they were able to regain the FDA approval they had lost in 2011.

Unlike the original inhaler, this new version does not use ozone-depleting chlorofluorocarbons (CFCs). Instead, is uses hydrofluoroalkanes (HFAs) as a propellant.

Asthma specialists and advocacy groups, however, have concerns about the renewed over the counter availability of this medication— here’s why:

What is Primatene Mist?

According to the Food & Drug Administration, Primatene Mist is FDA approved “to provide temporary relief for symptoms of mild, intermittent asthma.” It offers temporary relief to someone who is experiencing an asthma attack. It addresses wheezing, tightening of the chest, and shortness of breath… all symptoms that can cause incredible distress, anxiety, and even panic, in addition to the unpleasantness and discomfort they bring.

If you were around in the 1990s and old enough to remember television commercials of that era, you might recognize some of the Primatene Mist ads that used to run. There was always a close-up shot of a clock, ticking off 15 seconds. The implication was that relief was only 15 seconds away, if not less. Every commercial had a variation of this statement:

“It starts to open clogged breathing passages in as fast as 15 seconds.”

It was a common theme that ran throughout all the old commercials. It also served as the company’s slogan for the product:

“Fastest type asthma relief without a prescription.”

If you suffer from asthma, then you know the power that these words hold. As one retro commercial puts it: every second of an asthma attack can feel like an eternity.

Then why are allergy and asthma specialists issuing warnings, stressing deep concern over news of the drug’s comeback? It might help to understand how Primatene Mist works.

How Does Primatene Mist Work?

Primatene Mist is what’s known in medical circles as a “bronchodilator drug”. Almost everyone who has asthma uses some type of bronchodilator when symptoms arise.

As the name implies, the drug opens air passages in the lungs, expanding and relaxing them so people can breathe. The drug is delivered through an inhaler, although some types are delivered via a nebulizer mask. Primatene Mist comes in inhaler form and is small enough to be readily available as needed, on the go and unexpectedly. Your allergy and asthma specialist might call it a “rescue inhaler.”.

The active ingredient for both the original Primatene Mist and the newly-approved version is the same: epinephrine. Epinephrine is good old-fashioned adrenaline. In the body, adrenaline is a naturally-produced hormone that helps us combat stress. One of the ways it does this is by opening airways in the lungs, fast — hence the reason why it’s used for quick relief in asthma sufferers.

Epinephrine offers only temporary relief of mild asthma symptoms because it’s not strong enough to have the same impact as prescription asthma-controlling treatments. For this reason, epinephrine is not usually sufficient or recommended for someone who suffers regular attacks.

And this is where the concerns arise.

Primatene Mist Has a Powerful Impact on the Asthma Community…But Warnings are in Order

Before it was recalled, Primatene Mist was the only OTC asthma inhaler sold in the United States. It was immensely popular and even today, after seven years being off the market, it’s still a well-known brand. Even people who don’t suffer from asthma know the name. The brand has, in fact, reached generic name status, joining Kleenex, Bandaid, and Velcro. Try saying “over-the-counter asthma inhaler medication” or “epinephrine inhalation aerosol bronchodilator suspension” instead!

And no wonder it’s won a place in the hearts of American consumers: Primatene Mist had been around for half a century before it was recalled in 2011. It was — and still is — the number one trusted name in asthma treatments. As the old commercial went:

“At 3 AM, you do don’t try some unknown brand. You trust Primatene Mist.”

For the 26 million people who currently have asthma, a trusted brand brings a lot of comfort to their minds. So when the FDA pulled the product, there were a lot of unhappy people. Now that it’s back, the wave of sentiment is just as powerful, and that’s where the danger can be.

You see, even though Primatene Mist is a beloved product used by generations of asthma sufferers, it’s viewed somewhat differently by the medical community. Asthma specialists believe that asthma is most appropriately managed by routine evaluation, periodic lung function tests and prescription medications. Now that the new Primatene Mist is making a splash in the news, asthma specialists fear a tidal wave of misuse as consumers rush back to OTC solutions for a disease that’s better managed under the care of a board-certified allergy and asthma specialist.

OTC Meds are No Substitute for Seeing an Allergy and Asthma Specialist

The problem with the popularity and widespread use of Primatene mist is that it doesn’t completely treat asthma. It brings temporary symptoms relief but does not do anything to solve the problem or prevent the next attack. In fact, it could be dangerous in that it’s merely providing a band-aid solution for a potentially deadly disease that should be treated by a specialist. Anyone who feels the need to purchase Primatene Mist should certainly see an allergy and asthma specialist about asthma

“We know that the No. 1 reason 10 people die from asthma daily is due to lack of control and overuse of quick-relief medication”

~Tonya Winders, President & CEO at Allergy & Asthma Network

Self-medicating by taking OTC drugs is not a recommended long-term treatment plan. Asthma is a complex disease and requires regularly seeing a board-certified allergy and asthma specialist. There are several ways to keep asthma under control but unfortunately, Primatene Mist is not one of them.

“Asthma is not a ‘do-it-yourself’ disease that you can treat yourself with OTC medication.”

~Bradley Chipps, MD, ACAAI President

To be clear, the makers of Primatene Mist, do not claim to provide a long-term solution for serious asthma cases. Their use of the words “temporary relief” and “occasional symptoms” and “mild asthma” on the label speak to its inappropriateness as a long-term solution.

Still, experts are worried that people who use the product will be less likely to talk to their asthma doctor about their symptoms or even seek medical evaluation at all. That could lead to undiagnosed asthma, a disease that kills over 3500 people each year in the United States. If someone has asthma, temporary relief only delays what is truly necessary: seeing an asthma specialist for asthma testing and a tailored treatment plan to keep their asthma under control.

Our Bottom Line on Primatene Mist Usage:

If someone is using Primatene Mist they should see an allergy and asthma specialist for asthma as there are safer and better alternatives without the long-term side-effects of Primatene.